title: The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The Danish OPUS I trial randomized 547 patients with first-episode psychosis to a two-year early-specialised assertive treatment programme (OPUS) versus standard treatment. The two years OPUS treatment had significant positive effects on psychotic and negative symptoms, secondary substance abuse, treatment adherence, lower dosage of antipsychotic medication, and a higher treatment satisfaction. However, three years after end of the OPUS treatment, the positive clinical effects were not sustained, except that OPUS-treated patients were significantly less likely to be institutionalised compared with standard-treated patients. The major objective of the OPUS II trial is to evaluate the effects of five years of OPUS treatment versus two years of OPUS treatment.
  
  
  METHODS
  The OPUS II trial is designed as a randomized, open label, parallel group trial with blinded outcome assessment. Based on our sample size estimation, 400 patients treated in OPUS for two years will be randomized to further three years of OPUS treatment versus standard treatment. The specialized assertive OPUS treatment consists of three core elements: assertive community treatment, psycho-educational family treatment, and social skills training.
  
  
  CONCLUSIONS
  It has been hypothesized that there is a critical period from onset up to five years, which represents a window of opportunity where a long-term course can be influenced. Extending the specialized assertive OPUS treatment up to five years may allow the beneficial effects to continue beyond the high-risk period, through consolidation of improved social and functional outcome.
  
  
  BACKGROUND
  Clinical Trial.gov NCT00914238.
authors.affiliation: Psychiatric Centre Copenhagen, Copenhagen University, Faculty of Health Sciences, Copenhagen, Denmark. marianne.melau@regionh.dk
authors.forename: Marianne
authors.initials: M
authors.lastname: Melau
authors.forename: Pia
authors.initials: P
authors.lastname: Jeppesen
authors.forename: Anne
authors.initials: A
authors.lastname: Thorup
authors.forename: Mette
authors.initials: M
authors.lastname: Bertelsen
authors.forename: Lone
authors.initials: L
authors.lastname: Petersen
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Gertrud
authors.initials: G
authors.lastname: Krarup
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D015928:Cognitive Behavioral Therapy; D003156:Community Mental Health Services; D003419:Crisis Intervention; D003718:Denmark; D005196:Family Therapy; D006801:Humans; D011569:Psychiatric Status Rating Scales; D011615:Psychotherapy, Group; D011618:Psychotic Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D012919:Social Behavior; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents